FDA.reportPublic FDA data

Carisoprodol

Product NDC
50090-4263
11-digit product format
500904263
Labeler code
50090
Product ID
50090-4263_546efd21-a0d7-4d44-b40d-1a5cd61f6592
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA087499
Marketing category
ANDA
Marketing start
1987-11-01
Marketing end
0000-00-00
Substance
CARISOPRODOL
Active strength
350 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
780d53a1-1665-e26e-d112-85333c0c8a2eProduct name520220516
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4263-02023-01-30C16284748780-1f386c64a-4515-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
50090-4263-32023-01-30C16284748780-1f386c64a-4515-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
50090-4263-82023-01-30C16284748780-1f386c64a-4515-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959
50090-4263-92023-01-30C16284748780-1f386c64a-4515-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARISOPRODOL TABLETS safely and effectively. See full prescribing information for CARISOPRODOL TABLETS. CARISOPRODOL tablets for oral use, CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4263-0Carisoprodol30 in 1 BOTTLETABLET304
50090-4263-3Carisoprodol20 in 1 BOTTLETABLET204
50090-4263-8Carisoprodol60 in 1 BOTTLETABLET604
50090-4263-9Carisoprodol120 in 1 BOTTLETABLET1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4263CARISOPRODOL TABLET [A-S MEDICATION SOLUTIONS]4Legacy NDC, 4 package rows20200225_e46d612c-349a-4cf6-8452-d8625471754b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNe46d612c-349a-4cf6-8452-d8625471754b4
197446carisoprodol 350 MG Oral TabletSCDe46d612c-349a-4cf6-8452-d8625471754b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4263-05009042630030 TABLET in 1 BOTTLE (50090-4263-0) 30 tablet2019-04-100000-00-00NoNoCurrent
50090-4263-35009042630320 TABLET in 1 BOTTLE (50090-4263-3) 20 tablet2019-04-100000-00-00NoNoCurrent
50090-4263-85009042630860 TABLET in 1 BOTTLE (50090-4263-8) 60 tablet2019-04-100000-00-00NoNoCurrent
50090-4263-950090426309120 TABLET in 1 BOTTLE (50090-4263-9) 120 tablet2019-04-100000-00-00NoNoCurrent